ATH-1020 for Healthy Subjects

Overseen By Hans Moebius, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Athira Pharma

Must not be taking: Chronic medications

Disqualifiers: Drug allergies, Seizures, Hepatitis, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and behavior of a new treatment, ATH-1020, in the body. It focuses on healthy young and older adults, testing the treatment in both single and multiple doses. The trial includes two groups: one receiving ATH-1020 and another receiving a placebo (a pill with no active ingredients). Individuals who are generally healthy, with no serious allergies or recent surgeries, might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that participants do not use any chronic medications. If you use short-acting benzodiazepines or other treatments for insomnia and anxiety, you must stop using them during the screening period and throughout the study.

Is there any evidence suggesting that ATH-1020 is likely to be safe for humans?

Research shows that ATH-1020 is undergoing testing to determine its safety for humans. This marks the first use of ATH-1020 in people. The goal is to observe the body's reaction to the drug and identify any side effects.

Currently, there is no clear information on how well people tolerate ATH-1020 or what specific side effects might occur. As a first-in-human trial, the drug is in the early testing stages, meaning information about its safety in people is limited.

Despite the lack of previous human data, this phase of research focuses on ensuring the treatment's safety for further testing. Participants in these studies receive close monitoring for any negative effects, and researchers adjust dosages to establish a safe range. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ATH-1020 is unique because it offers a new approach to treatment in its potential condition, targeting pathways that current options might not address. Unlike traditional medications that may require frequent administration or injections, ATH-1020 is administered orally, which could improve patient comfort and compliance. Researchers are excited about its innovative mechanism of action, which could offer benefits where existing treatments fall short, providing hope for more effective management of the condition.

What evidence suggests that ATH-1020 could be effective?

Research suggests that ATH-1020, which participants in this trial may receive, could help treat symptoms related to Parkinson's disease. Studies have shown it positively affects a system that supports nerve cell health. Early research indicates that ATH-1020 might reduce depression-like symptoms and improve sensory information processing in conditions like schizophrenia. These initial findings are promising for its potential use in diseases affecting the brain and nerves. However, more research with human participants is needed to confirm these effects. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Part B (MAD)

You have a venous access device.

You are male and you are willing to comply with the contraceptive requirements of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of ATH-1020 or placebo to evaluate safety, tolerability, and pharmacokinetics

Up to 12 days

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple doses of ATH-1020 or placebo to evaluate safety, tolerability, and pharmacokinetics

Up to 19 days

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ATH-1020
• Placebo

How Is the Trial Designed?

Group I: ATH-1020 Experimental Treatment 1 Intervention

ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5).

Group II: Placebo Placebo Group 1 Intervention

Placebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo.

Who Is Running the Clinical Trial?

Athira Pharma

Lead Sponsor

Trials

8

Recruited

1,300+

Biotrial Inc.

Collaborator

Trials

2

Recruited

120+

Alturas Analytics, Inc.

Collaborator

Trials

2

Recruited

40+

Published Research Related to This Trial

HTX-019, a new injectable emulsion for preventing chemotherapy-induced nausea and vomiting (CINV), is bioequivalent to fosaprepitant but is better tolerated, leading to fewer adverse events.

The addition of neurokinin 1 receptor antagonists like HTX-019 to standard antiemetic regimens significantly improves CINV prophylaxis, addressing the need for safer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HTX-019: polysorbate 80- and synthetic surfactant-free neurokinin 1 receptor antagonist for chemotherapy-induced nausea and vomiting prophylaxis. Navari, RM.[2019]

HTX-019, an NK-1 receptor antagonist, was found to be safe for cancer patients undergoing chemotherapy, with no treatment-emergent adverse events directly related to the drug during the study.

In a retrospective analysis of 100 patients, only five reversible adverse events were reported during treatment cycles, indicating a favorable safety profile for HTX-019 as part of an antiemetic regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of antiemetic prophylaxis with HTX-019 as a 30-min infusion in patients with cancer: a retrospective study. Perry, TS., Dickson, N., Patton, JF.[2020]

HTX-019, a neurokinin 1 receptor antagonist, is effective in preventing nausea and vomiting in cancer patients undergoing chemotherapy, demonstrating a favorable safety profile during its administration.

In a retrospective analysis of multiple infusions in cancer patients, HTX-019 did not present any new treatment-emergent adverse events, confirming its tolerability in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of HTX-019 Administered as an Intravenous Infusion in Patients With Cancer: A Retrospective Analysis. Calcanes, G., Vacirca, JL.[2020]

A systematic review of antiemetic agents for preventing chemotherapy-induced nausea and vomiting (CINV) in children found that these medications, including aprepitant and ondansetron, are generally safe with manageable adverse effects.

While the recommended antiemetics are effective, it is important to consider individual patient risk factors, particularly for rare side effects like cardiac arrhythmia, and further research is needed to assess their long-term safety in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of clinical practice guideline-recommended antiemetic agents for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric patients: a systematic review and meta-analysis. Patel, P., Paw Cho Sing, E., Dupuis, LL.[2019]

HTX-019, a neurokinin 1 receptor antagonist, was evaluated in a study of 600 cancer patients and showed no treatment-emergent adverse events (TEAEs) within 60 minutes of administration, indicating a strong safety profile.

Administered as a 2-minute injection, HTX-019 is a viable option for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review. Navari, RM.[2020]

Citations

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athira.com/wp-content/uploads/2024/09/SfN-2024-ATH-1020-MOA-poster-Final-upload-1.pdf

ATH-1020

These data highlight the effects of ATH-1020 against PD-related pathology, supporting positive modulation of the neurotrophic HGF system as ...

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ATH-1020 by Athira Pharma for Neurodegenerative Diseases

According to GlobalData, Phase I drugs for Neurodegenerative Diseases have a 66% phase transition success rate (PTSR) indication benchmark for ...

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Athira Pharma Doses First Subject in Phase 1 Clinical Trial ...

Preclinical data demonstrates that ATH-1020 may reduce depression-like behaviors and rescue mismatch negativity response, a translatable measure ...

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finance.yahoo.com

finance.yahoo.com/news/athira-pharma-doses-first-subject-110000307.html

Athira Pharma Doses First Subject in Phase 1 Clinical Trial of ...

Preclinical data show ATH-1020 both mitigated depression-like behaviors and normalized sensory processing deficits in schizophreniaBOTHELL, ...

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Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

This trial tests a new drug called ATH-1020 in healthy young and elderly people to see if it is safe and how the body handles it.

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Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics ...

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clinicaltrialsarena.com

clinicaltrialsarena.com/news/athira-neuropsychiatric-treatment-trial/

Athira doses first subject in Phase I neuropsychiatric ...

The trial will assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ATH-1020. Vishnu Priya N April ...

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Athira Pharma Doses First Subject in Phase 1 Clinical Trial ...

Preclinical data demonstrates that ATH-1020 may reduce depression-like behaviors and rescue mismatch negativity response, a translatable measure ...